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Clinical Trials in the USA / NCT07220564
Recruiting Phase 1

A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A

NCT07220564 · tracked via the Priya Life Science USA tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 1
Started
2025-10-23
Last updated
2026-09-18

Condition(s) studied

Haemophilia A

Investigational drug(s) / intervention(s)

NNC0442-0344 A

NNC0442-0344 A: NNC0442-0344 A will be administered orally.

Study summary

This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.

Eligibility

Sex
MALE
Min age
18 Years
Max age
64 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Male * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body weight greater than or equal to (≥) 45 kilograms (kgs). * Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records. Exclusion Criteria: * Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening. * Body mass index ≥30.0 kilogram per square meter (kg/m\^2). * Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis. * Any clinical signs or established diagnosis of venous or arterial thromboembolic disease. * Any known coagulation disorders other than haemophilia A. * Ongoing or planned immune tolerance induction therapy. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
UC Denver Hemoph & Thrombo Ctr Aurora Colorado Recruiting
Indiana Hemophilia-Thromb Ctr Indianapolis Indiana Recruiting
University of Iowa_Iowa City Iowa City Iowa Recruiting
Penn State MS Hershey Med Ctr Hershey Pennsylvania Recruiting
St Christopher Hosp for Child Philadelphia Pennsylvania Recruiting
Universitätsklinik für Innere Medizin V Innsbruck Austria Recruiting
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie Vienna Austria Recruiting
Cliniques universitaires Saint-Luc Brussels Belgium Not Yet Recruiting
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique Bron France Active Not Recruiting
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain Berlin Germany Recruiting
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie Bonn Germany Not Yet Recruiting
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie Hanover Germany Recruiting
AOU Careggi Firenze Florence Italy Recruiting
Azienda Ospedaliera Universitaria Federico II di Napoli Naples Italy Recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok Poland Recruiting
Uniwersyteckie Centrum Kliniczne Gdansk Poland Recruiting
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach Katowice Poland Not Yet Recruiting
Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku Lublin Poland Not Yet Recruiting
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland Not Yet Recruiting
Instytut Hematologii i Transfuzjologii Warsaw Poland Recruiting
ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia Porto Portugal Recruiting
ULS São João, E.P.E._H.São João_Imunohemoterapia Porto Portugal Recruiting
Hospital Vall d'Hebron Barcelona Spain Recruiting
Hospital Universitario La Paz Madrid Spain Recruiting
Hospital Regional Universitario de Málaga Málaga Spain Recruiting
Hospital Clinico Universitario de Salamanca Salamanca Spain Active Not Recruiting
Hospital La Fe_Hemostasia y Trombosis Valencia Spain Active Not Recruiting
Skåne US - Koagulationsmottagning Malmö Sweden Recruiting
KS Solna - Koagulationsmottagningen Solna Sweden Recruiting
Zentrum für Labormedizin Sankt Gallen Switzerland Recruiting
Queen Elizabeth Hospital, Birmingham - Haemophilia Birmingham United Kingdom Recruiting
Royal Free Hospital - Haemophilia London United Kingdom Recruiting
Royal Hallamshire Hospital Sheffield United Kingdom Recruiting

More Novo Nordisk A/S trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220564 on ClinicalTrials.gov ↗ ← All trials in the USA